# K113260: Modified Concentirc Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Concentric Medical, Inc.
- Decided: Mar 9, 2012 after 126 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003086 (2001). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111619: Modified Concentric Microcatheter, Concentric Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K192122: Trevo Trak 21 Microcatheter (2019), 4 descendants of its own
- K211594: Trevo Trak 21 Microcatheter (2021), 2 descendants of its own
- K261889: Trevo Trak 21 Microcatheter (2026), 0 descendants of its own
- K250960: DUO Microcatheter (2025), 0 descendants of its own
- K202926: Micro Catheter (2022), 0 descendants of its own

## Recalls of this device
- Apr 23, 2024 · Class II · Z-1904-2024: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc
- Nov 28, 2017 · Class II · Z-0347-2018: Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
- Nov 3, 2017 · Class II · Z-0275-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c
- Nov 3, 2017 · Class II · Z-0276-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c
- Nov 3, 2017 · Class II · Z-0277-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c

## Indications for use
The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Source page: https://510kreport.com/device/K113260
Methodology: https://510kreport.com/methodology